Case Managers for CVD Risk Reduction in HIV Clinic

• ClinicalTrials.gov Identifier: NCT03839394
• Recruitment Status: Recruiting
• First Posted: February 15, 2019
• Last Update Posted: February 24, 2022
• Sponsor: Duke University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

The purpose of the study is to assess the efficacy of a case manager/social worker administered, telephone-based educational curriculum in improving cardiovascular disease related outcomes among HIV-infected clinic patients.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Disease; HIV	Behavioral: Telephone; Other: Educational pamphlets	Not Applicable

Detailed Description:

Fifty high Cardiovascular Disease Risk (CVD) risk clinic patients will be randomized 1:1 to receive either a series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum delivered over 24 weeks [intervention arm], or the educational pamphlets alone [control arm]. Anthropomorphic data, blood pressure and lipid profiles will be obtained from patients to assess the efficacy of the intervention in reducing blood pressure and serum low-density lipoprotein levels (LDL).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Clinic-Based Case Manager Administered Telephone Intervention to Reduce Cardiovascular Disease Risk in Persons Living With HIV
• Actual Study Start Date: October 12, 2020
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: April 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Educational pamphlets + telephone	Behavioral: Telephone; A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.; Other: Educational pamphlets; A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
Active Comparator: Educational pamphlets	Other: Educational pamphlets; A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.

Outcome Measures

Primary Outcome Measures :

1. Change in ambulatory systolic blood pressure [ Time Frame: baseline, 24 weeks, 48 weeks, 72 weeks ]
   Change of systolic blood pressure will be assessed as an absolute continuous variable, and as a proportion or persons who achieve >5mmHg reduction in systolic blood pressure from baseline
2. Change in fasting LDL-c levels [ Time Frame: baseline, 24 weeks, 48 weeks, 72 weeks ]
   Assessment of the absolute change in fasting calculated low density lipoprotein cholesterol over the study period.

Secondary Outcome Measures :

1. Total weight loss [ Time Frame: baseline, 24 weeks, 48 weeks, 72 weeks ]
   Total weight loss from baseline over the study period.
2. Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk score [ Time Frame: baseline, 24 weeks, 48 weeks, 72 weeks ]
   The global cardiovascular disease risk as calculated by the American College of Cardiology/American Heart Association's 10-year risk calculator.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• In care at the Duke Infectious Diseases Clinic for HIV and for at least 24 months
• On antiretroviral therapy
• 2013 American Heart Association 10-year ASCVD risk score ≥ 15%, with a diagnosis of either hypertension or hyperlipidemia
• English literate (able to speak and read at a 6th grade level)
• Subjects must have the capacity to give legally effective consent.

Exclusion Criteria:

• Patients with prior diagnosis of acute coronary syndrome, stroke, peripheral vascular disease, and end stage renal disease

Contacts and Locations

Contacts

Contact: Caroline Questell; (919) 668-5142; caroline.darragh@duke.edu

Contact: Katherine Link; 919-668-0161; katherine.link@duke.edu

Locations

United States, North Carolina

Duke University Medical Center; Recruiting

Durham, North Carolina, United States, 27701

Contact: Nwora L Okeke, MD, MPH

Sponsors and Collaborators

Duke University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Nwora L Okeke, MD, MPH; Duke University

More Information

Additional Information:

Website referring to educational materials to be shared as part of this intervention 

Website referring to educational materials to be shared as part of this intervention 

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT03839394
• Other Study ID Numbers: Pro00085562; K23HL137611-01A1 ( U.S. NIH Grant/Contract )
• First Posted: February 15, 2019
• Last Update Posted: February 24, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cardiovascular Diseases